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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K113543
Device Name ONDEMAND3D
Original Applicant
CYBERMED, INC.
#504 sj technoville,
gasan-dong 60-19, geumcheon-gu
seoul,  KS 153-710
Original Contact yong ki im
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/01/2011
Decision Date 12/16/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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